AI-guided access

Easy Expert navigates the structure.

Easy Expert works on the Easy13485 data and reference model — processes, roles, templates, evidence logic and IPP expertise, structured and source-bound. Not a generic AI answer engine. The right context for wherever you are in the Journey. IPP experts own the gates that matter.

Your first point of contact

A structured way to navigate your QMS work.

The AI-guided access layer to the Easy13485 data and reference model. It works source- and model-bound — on processes, roles, templates, evidence logic and the accumulated IPP expertise built into the Easy13485 structure. Not a generic chatbot. Not a standard search. It navigates your QMS and regulatory work exactly where you are in the Journey.

Context

Answers with context & references

Every answer is aligned with Easy13485 logic and can reference the relevant process and chapter — audit-friendly by design.

Role-aware

Role- and team-aware

Responds differently to QMR, PRRC, D&D Software, Purchasing or Management — in the right language and depth.

Templates

Template guidance

Supports AI-assisted completion of templates — correctly structured, consistent and aligned with your QMS.

Trained on Easy13485

See Easy Expert in action.

Easy Expert
AI-guided access to your Easy13485 structure
LIVE DEMO
Ask:
▌
Easy Expert First AI. Then consultants. You stay in the flow.

Easy Expert · three tiers

AI access that fits where you are.

Not a generic AI chatbot. A structured access layer to the Easy13485 data and reference model — processes, roles, templates, evidence logic and IPP expertise. Three tiers. One source of truth.

Easy Expert General

Orientation. For everyone. Included.

General Easy13485, PLC, MDR and clinical orientation on the basis of the Easy13485 structure — from day one, across all product lines and Journey stages, at no extra cost.

  • Easy13485 process and role orientation
  • MDR / ISO 13485 questions with Easy13485 context
  • Template and evidence guidance
  • Role-aware answers for QMR, PRRC, D&D, Management
Availability All product lines · All stages · No extra cost
Easy Expert Custom

Your scope. Your data. Dialogue-ready.

Built on your approved Easy13485 scope and approved customer data. It replaces a large share of recurring search, explanation, onboarding and template loops — without replacing responsibility or formal sign-off.

  • Answers based on your specific QMS scope and roles
  • Step-by-step guidance through your templates and processes
  • Reduces recurring consulting, search and onboarding loops
  • Founder, QMB, PRRC, Regulatory, Development, Management
Availability Essential & Certified · from Automate · +390 €/month
Config License

QMS logic inside your build pipeline.

The Config License connects your own AI, RAG, GPT, agent or software development environments to the Easy13485 QMS and development logic. Technical changes reach regulatory-ready draft structure earlier — without leaving your pipeline. Includes Easy Expert Custom.

  • Connects repositories, tickets, builds to QMS logic
  • Drafts requirements, change plans, test cases, release reports
  • For CTO, SaMD teams, software leads and AI development teams
  • Includes Easy Expert Custom
Availability Essential & Certified · from Automate · +890 €/month

Easy Expert does not replace formal approval, professional review or regulatory responsibility. It reduces search, explanation and routine loops — and makes IPP expertise more effective at the points that matter.

Human quality layer

AI for speed. Experts for certainty.

Easy Expert keeps you moving — answering instantly, guiding you through Easy13485 processes and helping prepare the right documents in the right context. But regulatory confidence doesn't come from speed alone. That's why the Makerspace always includes a human quality layer: experts step in at defined points, review critical outputs and validate decisions where it matters most.

Speed

Immediate guidance

AI delivers instant orientation and guidance along the Easy13485 structure.

Flow

Your team stays productive

Less search, explanation and routine work — the team stays in flow.

Certainty

Experts as quality gate

IPP experts act as quality gate and safety net at key milestones.

You decide

Start smart. Choose how to begin.

A simple entry into professional compliance and quality management for startups — pick the path that fits where you are.

Start free

Start your MedTech Journey

Build the right foundation: Manufacturer Obligations Assessment, certificate on completion, and a first consulting call included — free.

Start the free e-learning
Direct

Direct consulting

Start immediately with tailored expert support. First consulting, 120 € (45 min), no prerequisites — startup-focused, practical guidance.

Book a consulting call
AI-Guided Access

Easy Expert works on the Easy13485 data and reference model — processes, roles, templates, evidence logic and IPP expertise, structured and source-bound. Not a generic AI answer engine. The right context for wherever you are in the Journey.

Easy Expert navigates the structure. IPP experts own the gates that matter.

Your First
Point of Contact

Easy Expert is the AI-guided access layer to the Easy13485 data and reference model. It works source- and model-bound — on processes, roles, templates, evidence logic and the accumulated IPP expertise built into the Easy13485 structure. Not a generic chatbot. Not a standard search. A structured way to navigate your QMS and regulatory work exactly where you are in the Journey

Trained On Easy13485

Easy Expert
AI-guided access to your Easy13485 structure
LIVE DEMO
Ask:
▌
Easy Expert First AI. Then consultants. You stay in the flow.

Answers with context & references

Every answer is aligned with Easy13485 logic and can reference the relevant process and chapter — audit-friendly by design.

Role- and team-aware

Responds differently to QMR, PRRC, D&D Software, Purchasing, or Management — in the right language and depth.

Template guidance

Supports AI-assisted completion of templates — correctly structured, consistent, and aligned with your QMS.

Easy Expert · Three tiers

AI access that fits where you are.

Easy Expert is not a generic AI chatbot. It is a structured access layer to the Easy13485 data and reference model — processes, roles, templates, evidence logic and IPP expertise. Three tiers. One source of truth.

Easy Expert General

Orientation. For everyone. Included.

General Easy13485, PLC, MDR and clinical orientation on the basis of the Easy13485 structure. Available from day one, across all product lines and all Journey stages at no additional cost.

  • Easy13485 process and role orientation
  • MDR / ISO 13485 questions with Easy13485 context
  • Template and evidence guidance
  • Role-aware answers for QMR, PRRC, D&D, Management
Availability All product lines · All stages · No extra cost
Easy Expert Custom

Your scope. Your data. Dialogue-ready.

Easy Expert Custom is built on your approved Easy13485 scope and your approved customer data. It replaces a large share of recurring search, explanation, onboarding and template guidance loops — without replacing responsibility or formal sign-off.

  • Answers based on your specific QMS scope and roles
  • Step-by-step guidance through your templates and processes
  • Reduces recurring consulting, search and onboarding loops
  • Founder, QMB, PRRC, Regulatory, Development, Management
Availability Essential & Certified · from Automate · +390 €/month
Config License

QMS logic inside your build pipeline.

The Config License connects your own AI, RAG, GPT, agent or software development environments to the Easy13485 QMS and development logic. Technical changes reach regulatory-ready draft structure earlier — without leaving your pipeline. Includes Easy Expert Custom.

  • Connects repositories, tickets, builds to QMS logic
  • Drafts requirements, change plans, test cases, release reports
  • For CTO, SaMD teams, software leads and AI development teams
  • Includes Easy Expert Custom
Availability Essential & Certified · from Automate · +890 €/month

Easy Expert does not replace formal approval, professional review or regulatory responsibility. It reduces search, explanation and routine loops — and makes IPP expertise more effective at critical points.

AI For Speed
Experts For
Certainty

Easy Expert is designed to keep you moving — answering questions instantly, guiding you through Easy13485 processes, and helping you prepare the right documents in the right context.

But regulatory confidence doesn’t come from speed alone.

That’s why the Makerspace always includes a human quality layer.
Our experts step in at defined points along your journey — reviewing critical outputs, validating decisions, and providing reassurance where it matters most.

The result is a controlled process where:

AI delivers immediate guidance and orientation

Your team stays productive and in flow

Experts act as quality gate and safety net at key milestones

Capabilities
Easy13485 Journey

📄

Evidence

Claims, development and evidence — traceable from day one.

💻

Easy Expert

AI-supported access to Easy13485 roles, processes and templates.

🎓

Academy

Role-based training with documented competence.

⚙️

QMSaaS

A maintained QMS workspace for daily operation.

🧾

Readiness Audit

Checks, findings and audit-oriented preparation

Contact us
You Decide

Start smart. Choose how you want to begin.

For startups, we offer a simple entry into professional compliance and quality management.

Start your Medtech Journey

Build the right foundation and get rewarded.

  • “16 Obligations of a Manufacturer” course
  • Certificate after completion
  • First consulting call included – free
  • Assessment for Claim Check
Start the free E-learning

Direct Consulting

Start immediately with tailored expert support.

  • First consulting
  • 120€ (45 min)
  • No prerequisites
  • Startup-focused, practical guidance
Book a Consulting Call (120 € / 45 min)
ipp.

Contact

  • Kerschensteinerstr. 79
    90471 Nürnberg
  • kontakt(at)ipp-nbg.com

Office hours

Monday to Friday
8:00 am - 2:00 pm